Quality Technician

Injectech LLC; Fort Collins (CO); On-site; USD 42,000 - 62,000; Full time

Benefits offered by this job

401(K) Retirement Plan

Profit Share Program

Medical, Dental, Vision, Life & AD&D

Job summary

Injectech, LLC is seeking a Quality Inspector to ensure product conformity and compliance with ISO 13485 and GDP standards. The role focuses on incoming material inspection, process testing, and data recording in a Fort Collins, CO environment.

The ideal candidate has a high school diploma, basic math skills, experience with inspection tools, and strong attention to detail. This is an on-site position with participation in internal audits and continuous improvement initiatives.

Qualifications

• High school diploma or equivalent is required; technical training or certification is preferred.
• Experience in quality inspection or regulated manufacturing environments is preferred.
• Cleanroom familiarity and willingness to complete gowning/training are required.
• Solid understanding of GDP, GDP controlled documentation, and ISO 13485 principles.

Responsibilities

• Inspect incoming materials, in-process components, and finished products per established specs and work instructions.
• Collect, record, and analyze inspection data with GDP; ensure documentation accuracy.
• Review product and process docs to verify conformance with requirements.
• Identify nonconforming materials and communicate disposition per procedures.
• Support investigations into quality issues and corrective actions.
• Maintain quality records per QMS and company procedures.

Skills

Attention to detail

Reading drawings

English communication

Teamwork

Multitasking

Education

High school diploma or equivalent

Technical training preferred

Tools

GDP documentation practices

ISO 13485 knowledge

eQMS familiarity

Calibrated measuring equipment

Job description

Injectech, LLC has been a trusted supplier of fluid-control components for over 20 years. Our current senior management team has been with Injectech since the very beginning, bringing extensive knowledge of the medical device industry to every project.

Our employees are important to us! We want the best for our employees, not just at work, but through all aspects of their life. That is why we offer comprehensive benefits including health insurance, a 401(k) plan with up to 6% company match, and access to free financial advice about retirement, debt, and any future financial needs from a licensed Financial Advisor. We strongly believe that the only way for our company to be successful is to make sure our employees have healthcare, mental healthcare, retirement options and financial education available to them.

We work hard to create a culture that promotes open lines of communication, a flexible work-life balance, continuous improvement in every department, and a place where employees want to be every day. We strive to hire and retain the best people, because we know a company is only as good as its employees. We hope you will join our team as we continue to grow and improve!

This position will remain open until filled.

Location: On-site in Fort Collins, CO

Schedule & Hours: Sun-Thurs , 6:30am-3:00pm

Essential Duties & Responsibilities:

• Perform inspection and testing of incoming materials, in-process components, and finished products according to established specifications, procedures, and work instructions.
• Collect, record, and analyze inspection and test data accurately and in accordance with Good Documentation Practices (GDP).
• Review product and process documentation to verify compliance with established requirements.
• Identify, document, and communicate nonconforming materials, components, or products in accordance with established procedures.
• Support the evaluation and disposition of nonconforming product, including appropriate containment and corrective actions.
• Perform quality inspections using calibrated measuring equipment and other applicable inspection tools.
• Read and interpret technical drawings, specifications, and work instructions to perform inspections and determine product conformity.
• Verify that materials and products meet applicable requirements prior to release, as authorized by established procedures.
• Support investigations into quality issues, customer concerns, and production-related quality problems.
• Assist with continuous improvement activities and recommend opportunities to improve product quality, inspection methods, and manufacturing processes.
• Maintain accurate and complete quality records in accordance with company procedures and the Quality Management System (QMS).
• Follow applicable ISO 13485, QMS, safety, cleanroom, and company requirements.
• Maintain a clean, orderly, and safe work area and follow applicable cleanroom gowning and environmental requirements.
• Participate in internal audits, quality projects, training, and other quality-related activities as assigned.
• Maintain current knowledge of applicable quality requirements, inspection methods, and industry practices through training and other professional development activities.
• Perform other duties as assigned.

Qualifications & Skills:

• High school diploma or equivalent required; technical training, certificate, or related education preferred.
• Previous experience in quality inspection, manufacturing, medical device manufacturing, or another regulated manufacturing environment preferred.
• Experience working in a cleanroom environment preferred; willingness and ability to complete required cleanroom gowning and training required.
• Working knowledge of ISO 13485 and quality management system principles preferred.
• Working knowledge of Good Documentation Practices (GDP) and controlled documentation.
• Experience using calibrated measuring and inspection equipment preferred.
• Ability to read and interpret technical drawings, specifications, and work instructions.
• Basic understanding of quality control methods, inspection techniques, and statistical concepts.
• Familiarity with electronic Quality Management Systems (eQMS), ERP systems, and other quality or manufacturing software preferred.
• Proficiency with Microsoft Office applications (Excel, Word, etc.)
• Strong attention to detail and organizational skills.
• Strong written, verbal, and interpersonal communication skills in English.
• Ability to manage multiple priorities and deadlines with limited supervision.
• Ability to perform basic mathematical calculations, including addition, subtraction, multiplication, division, measurements, and decimals.
• Ability to work effectively both independently and as part of a team.
• Demonstrated commitment to quality, safety, efficiency, and continuous improvement.

Work Environment & Physical Demands:

• Ability to sit, stand, and walk for extended periods throughout the workday (up to 8 hours).
• Ability to communicate verbally, hear clearly, and maintain corrected vision sufficient for reading, writing, inspecting components, and completing required documentation.
• Physical agility to bend, kneel, reach, and work in various positions while performing repetitive and detail-oriented tasks.
• Ability to lift and/or move up to 50 lbs., with or without reasonable accommodation.
• Requires manual dexterity and hand-eye coordination for handling small components, inspection equipment, tools, and other materials.
• Comfortable working in manufacturing environments with varying temperatures, noise levels, and exposure to industrial materials.
• Comfortable working in cleanroom environments,following all applicable cleanroom gowning, hygiene, PPE, safety, and contamination-control requirements.

Benefits

• 401(K) Retirement Plan
• Profit Share Program
• Medical, Dental, Vision, Life & AD&D Insurance, Short Term Disability (STD), Long Term Disability (LTD), Supplemental Insurance Plans, and Employee Assistance Program (EAP)
• Sick Time, Vacation Time, Holiday Pay, Volunteer Time Off (VTO), and Bereavement

Drug Testing Policy

Injectech is committed to maintaining a safe and productive workplace. As part of this commitment, all potential employees must pass a drug screening as a condition of employment. The drug test is a 5-panel screening and must be completed to your start date.

Injectech is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, or any other characteristic protected by law. We are committed to creating a diverse and inclusive workplace and encourage candidates from all backgrounds to apply.